Australia’s TGA Seeks Comments on Unique Device Identification System

Australia’s Therapeutics Goods Agency (TGA) has issued a new draft guidance on its plan to establish a unique device identification (UDI) system and is calling for comments from devicemakers.

Under the proposed system, sponsors that import or supply devices in Australia would need to verify that device manufacturers have assigned a UDI to their device and have placed it on the device on labeling and on packaging. 

TGA noted that U.S. and EU regulators are introducing UDIs in stages, starting with higher-risk devices and said it expects to take a similar approach.